Group of male cancer drug immunotherapy drugs (on) - experts suggest that rational entry into the PD-1/PD-L1 antibody drug market February 23, 2017 Source: China Medical News The antibody drug of programmed cell death protein-1 (PD-1) and its ligand PD-L1 has brought about a breakthrough in cancer therapy. Although there are only three drugs on the market in the world, the research and development competition of PD-1/PD-L1 antibody drugs has been heated up in both the international market and the Chinese market. A large number of funds have madly entered this field. In order to enable relevant enterprises and investors to fully understand PD-1/PD-L1 antibody drugs, master relevant market conditions and research and development progress, and be alert to investment overheating and homogenization risks, this edition will be divided into two journals and sent to reporters for investigation and interview. The article hopes to provide a reference for interested readers. On February 2, the American Society of Clinical Oncology (ASCO) released the 2017 annual report entitled "Clinical Cancer Progress", which included Immunotherapy 2.0 as the annual progress this year. This is a recognition of the growing development of cancer immunotherapy, an innovative treatment that effectively extends and improves the lives of cancer patients. This is also the case. Currently, as a hot spot for cancer immunotherapy, the antibody of programmed cell death protein-1 (PD-1) and its ligand PD-L1 is favored by developers and investors. Then, what is the current international research and development of PD-1/PD-L1 antibody drugs, and what is the competition pattern in the domestic and international markets? Our reporter recently interviewed relevant industry experts. Treating cancer advantages Dr. Li Guochun, Senior Director of Biopharmaceutics, Harbin Yuheng Pharmaceutical Co., Ltd., said that cancer is currently a serious threat to human health. Classical cancer treatments are cytotoxic chemotherapeutics, such as cisplatin, carboplatin, paclitaxel, pemetrexed, gemcitabine, etc., in addition to killing cancer cells will kill normal cells. In recent years, targeted therapeutic drugs, such as the small molecule targeting drug imatinib, the macromolecular targeting drug bevacizumab, trastuzumab, panitumumab, etc., have been triggered by specific gene mutations. Cancer has a good therapeutic effect, while the toxic side effects are relatively reduced, which improves patient compliance, but the emergence of drug resistance also greatly limits the possibility of long-term patient benefit. “Currently, the rapid development of drug development for PD-1/PD-L1 is due to its breakthrough in cancer treatment.†Yu Dechao, chairman of Suzhou Cinda Biopharmaceutical (Suzhou) Co., Ltd., said that humans The treatment of cancer, whether using traditional chemoradiotherapy or modern targeted therapies, does not solve the substantive problems. It was not until the advent of immunotherapy technology that revolutionized the treatment of cancer. At present, the successful areas and research hotspots of cancer immunotherapy mainly focus on "immunization checkpoint inhibitors". Different from traditional chemotherapy and targeted therapy, it overcomes the immunosuppression in patients and reactivates the patient's own immune cells to kill tumor cells. It is a brand new anti-cancer treatment concept. Dr. Zhou Feng, Thomson Reuters product and solutions expert, explained that cancer immunotherapy uses the body's own immune function to attack tumor cells and destroy them, including the use of immunological checkpoint inhibitors, tumor vaccines, and cell therapy (CAR-T). Wait. Among them, the results of immunological checkpoint inhibitors are the most concerned. Among immunological checkpoint inhibitors, PD-1 and PD-L1 are the two major targets. Li Guochun pointed out that in recent years, cancer immunotherapy represented by immunological checkpoint antibodies (such as PD-1, PD-L1 antibody, CTLA-4, etc.) and CAR-T has developed rapidly, and has shown excellent efficacy in clinical research. The long-term benefit of the patient is significant. In particular, PD-1/PD-L1 antibody drugs have become the core development direction of cancer immunotherapy because of their remarkable curative effect, wide indications, small side effects and relatively low treatment costs. Wu Wenjun, director of R&D of Gan Li Pharmaceutical Co., Ltd., also said that the development of PD-1/PD-L1 antibody drug is due to its breakthrough efficacy, although the overall response rate is not high, but for many indications that are not available for medicine or It has a good effect in preventing cancer progression, such as advanced melanoma and recurrent non-small cell lung cancer. In addition, in many combinations with other chemotherapeutic drugs and antibody drugs, these drugs also show an effect of improving the efficacy, which also promotes its rapid development. In 2013, the New York Times (New York Times) and Science (Science) all ranked cancer immunotherapy as a major breakthrough. In 2016, ASCO's annual research progress report also named immunotherapy as the largest advancement in cancer research in 2015. Pharmaceutical giants "staking a horse" As an important member of biopharmaceuticals, PD-1/PD-L1 antibody drugs are a hot spot for immunotherapy and a frontier for pharmaceutical giants. "50% to 70% of research and development resources are invested in the research and development of cancer immunotherapy drugs." Yu Dechao said that currently, there are only three PD-1/PD-L1 antibody drugs listed globally, but many in clinical research. In 100, the number of related research projects is no less than 1,000. Zhou Feng said that according to Cortellis data from Corey Wei'an (formerly Thomson Reuters Intellectual Property and Technology Group), the global drug-related drugs related to the PD-1/PD-L1/PD-L2 target are available worldwide. 108. It is understood that the PD-1 antibody drugs currently available in the international pharmaceutical market, and the Nivolumab (trade name Opdivo) of Bristol-Myers Squibb (BMS) were approved for listing in Japan in July 2014. The world's first marketed PD-1 antibody drug; Merck's (MSD) pembrolizumab (trade name Keytruda), approved by the US Food and Drug Administration (FDA) in September 2014, is approved by the FDA The first PD-1 drug. The marketed PD-L1 antibody drug is Roche's Atezolixumab (Tecentriq), which was launched in May 2016 and is the world's first approved PD-L1 antibody. Li Guochun told reporters that the three drugs in the comparison with traditional treatment methods such as chemotherapy, patients benefited significantly, have obtained the FDA breakthrough drug status. Currently, indications for PD-1/PD-L1 antibody drugs have been approved include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and head and neck cancer. Indications for clinical research include breast cancer, hepatocellular carcinoma, ovarian cancer, gastric cancer, colon cancer, and lymphoma. Wu Wenjun said that among the three listed drugs, the competition between BMS Opdivo and MSD's Keytruda is particularly striking. First, the clinical phase of Keytruda was directly expanded to 1000 cases, and the rolling report was first listed in the United States. Opdivo took the lead in taking second-line treatment for non-small cell lung cancer, but unexpectedly failed on more important first-line treatment. Since then, both sides have chased after me, and have successively launched a series of clinical trials for different cancer indications, such as liver cancer, bladder cancer, stomach cancer, head and neck cancer, breast cancer and ovarian cancer. Several rounds have been compared, and overall there are wins and losses. In addition to the repeated upgrades in clinical trials and the pace of listing, the two sides also fought a patent war. In January of this year, BMS won the global patent war of PD-1 antibody drugs and reached a settlement agreement with MSD, which paid the former 625 million US dollars and 6.5% sales commission (January 1, 2017 to December 31, 2023) Or 2.5% sales commission (January 1, 2024 ~ December 31, 2026). 2015 was the first full sales year for BMS Opdivo, which achieved sales of $942 million with three approved indications; MSD was outdated in the approval of the indications, making its 2015 sales only 566 million US dollars. In 2016, Opdivo's sales reached $4.6 billion; Keytruda also rose to $1.4 billion. At present, the clinical trials of these two products for other cancer types are actively underway, and the continued positive news of multiple indications has also stimulated the increase in the predicted value of product sales. Li Guochun said: "Accord by EvaluatePharma, a world-renowned pharmaceutical market research organization, Opdivo will be the most successful PD-1 cancer immunotherapy. Its annual sales in 2020 will reach 8 billion US dollars, while Keytruda's sales will reach 40. In addition, FiercePharma recently announced its forecast of the world's best-selling 15 anti-tumor drugs in 2022. Opdivo2022 sales are expected to reach $12.62 billion, Keytruda is expected to reach $5.66 billion, and Tecentriq is expected to reach $5.53 billion. The sales of these three drugs will total more than 20 billion US dollars, and the market potential is huge. Of course, the "bovine" drugs will not only have a few international pharmaceutical giants scramble for the split. "At present, almost all multinational pharmaceutical companies are investing in drug development such as PD-1/PD-L1. The related transactions are large in quantity and amount, and their heat is evident." Zhou Feng said . Li Guochun said that in addition to BMS, MSD and Roche, foreign pharmaceutical companies such as Pfizer, AstraZeneca, Novartis, Eli Lilly and Sanofi have also entered the market. Multiple PD-1/PD-L1 antibody drugs are in clinical use. In the test. The Thomson Reuters Cortellis database shows that PDNOL antibody, such as REGN2810 from Sanofi and Regeneron, PD1 antibody from Novartis PDR-001, BMS-936559 from BMS, and LY-3300054 from Lilly are also under research. . (Reporter Bai Yi) Manual Massage Collapsible Foot Spa Massager The Manual Massage Foldable Foot Spa Massager is a portable compact device designed to give your feet a relaxing massage experience. 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Group of male cancer drug immunotherapy drugs (on) - experts suggest that rational entry into the PD-1/PD-L1 antibody drug market